Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12608000106336
Ethics application status
Approved
Date submitted
22/02/2008
Date registered
27/02/2008
Date last updated
25/11/2019
Date data sharing statement initially provided
25/11/2019
Date results information initially provided
25/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
VENTRASSIST® exercise study in heart failure patients
Scientific title
Investigation into the effect of pump speed on exercise capacity in VENTRASSIST™ left ventricular assist patients
Secondary ID [1] 299902 0
NA
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Exercise capacity 2860 0
Condition category
Condition code
Cardiovascular 2993 2993 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Exercise capacity, relationship between pump speed and oxygen consumption (VO2 max) measured at three pump speeds over a three day period, VENTRASSIST®, left ventricular assist device
Intervention code [1] 2588 0
Not applicable
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3874 0
Relationship between pump speed and oxygen consumption, measured as peak exercise oxygen consumption (VO2) in ml/kg/min at each speed setting
Timepoint [1] 3874 0
Day 1,2 and 3 of exercise
Secondary outcome [1] 6519 0
Investigation of patient's anaerobic threshold at different pump speeds
Timepoint [1] 6519 0
Day 1, 2 and 3 of exercise
Secondary outcome [2] 6520 0
Examining effects of different pump speeds during maximal exercise on patient's cardiopulmonary measurements
Timepoint [2] 6520 0
Dat 1, 2 and 3 of exercise

Eligibility
Key inclusion criteria
VentrAssist left ventricular assist device implanted, signed informed consent, age greater than or equal to 18 years, clinically stable as assessed by cardiologist, ambulatory
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Active infection, exercise induced myocardial ischaemia or significant arrhythmias, inability to achieve a significant increase in left ventricular assist device flow without risk of suction as determined by clinical judgment, VENTRASSIST® left ventricular assist device implant duration less than 2 months

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2008
Actual
1/03/2008
Date of last participant enrolment
Anticipated
Actual
30/06/2009
Date of last data collection
Anticipated
Actual
31/07/2009
Sample size
Target
30
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment postcode(s) [1] 585 0
2010
Recruitment postcode(s) [2] 586 0
3004

Funding & Sponsors
Funding source category [1] 3111 0
Commercial sector/Industry
Name [1] 3111 0
VENTRACOR Limited
Country [1] 3111 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
VENTRACOR Limited
Address
126 Greville Street
Chatswood, NSW, 2067
Country
Australia
Secondary sponsor category [1] 2800 0
None
Name [1] 2800 0
Address [1] 2800 0
Country [1] 2800 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5089 0
St Vincent's Hospital
Ethics committee address [1] 5089 0
Level 6, de Lacy Building
St Vincent's Hospital
390 Victoria Street,
Darlinghurst NSW 2010
Ethics committee country [1] 5089 0
Australia
Date submitted for ethics approval [1] 5089 0
Approval date [1] 5089 0
23/10/2007
Ethics approval number [1] 5089 0
07/SVH/28

Summary
Brief summary
To evaluate the exercise capacity of patients implanted with a VENTRASSIST® left ventricular assist device
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28393 0
A/Prof Chris Hayward
Address 28393 0
St Vincent's Hospital, 390 Victoria St, Darlinghurst, NSW, 2010
Country 28393 0
Australia
Phone 28393 0
+61 2 8382 1111
Fax 28393 0
Email 28393 0
Unknown
Contact person for public queries
Name 11550 0
Dr John Woodard
Address 11550 0
126 Greville St
Chatswood, NSW, 2067
Country 11550 0
Australia
Phone 11550 0
+61 2 9406 3102
Fax 11550 0
+61 2 9406 3111
Email 11550 0
[email protected]
Contact person for scientific queries
Name 2478 0
Dr John Woodard
Address 2478 0
126 Greville St
Chatswood, NSW, 2067
Country 2478 0
Australia
Phone 2478 0
+61 2 9406 3102
Fax 2478 0
+61 2 9406 3111
Email 2478 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data estimated as company went into voluntary administration and exact information unknown.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseImpact of left ventricular assist device speed adjustment on exercise tolerance and markers of wall stress.2015https://dx.doi.org/10.5301/ijao.5000431
N.B. These documents automatically identified may not have been verified by the study sponsor.